“So many of us are clinging to unproven care” Book review by Evi Heilbrunn 12/22 in The Philadelphia Inquirer

Every morning, I take a One-a-Day women’s multivitamin. The label advertises how the pill is “formulated to support” everything from bone strength to heart health. Taking the pill always makes me feel proactive about my health. I never doubted the common view that “vitamins are good for you.”

In Do You Believe in Magic?: The Sense and Nonsense of Alternative Medicine, Paul A. Offit, chief of the division of infectious diseases at Children’s Hospital of Philadelphia, delivers an epic critique of vitamins, the supplement industry, and our vulnerability to quackery.

First, he notes the Food and Drug Administration does not guarantee the quality or dosage of vitamins and supplements.

Sure enough, when I looked closely at my One-a-Day bottle, a scripted sentence stood out: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Though in plain sight, I had never bothered to read this. Offit assures me I’m not alone. In 2012, more than half the U.S. population took some kind of vitamin despite the fact there’s no proof they improve health. Indeed, Offit cites strong evidence showing that high doses of some vitamins are linked to higher rates of cancer and heart disease. (Two major studies last week found multivitamins failed to protect aging men’s brains or help heart attack survivors. An editorial urged consumers to “stop wasting money.”)

In this easy-to-read and meticulous book, Offit goes after personalities such as Suzanne Somers, Deepak Chopra, and Dr. Oz for extolling unproven care.

Offit tells how laetrile, an alleged cancer cure from apricot pits, failed actor Steve McQueen and Joey Hofbauer, 7, who likely would be alive today if he had had conventional cancer care.

Offit dwells on the work of Nobel-winning chemist Linus Pauling, whose 1970book, Vitamin C and the Common Cold, declared that a daily 3,000-milligram dose was the cure. Pauling went on to assert that large, daily doses of vitamins could cure ailments from heart disease to AIDS.

Many Americans still believe vitamin C helps fight the common cold, even though evidence shows no such effect.

False pitches have helped make supplements a $34 billion industry. Many hospitals and doctors play along, although Offit’s hospital recently became the first to discourage patients from taking most supplements.

He delves into why alternative therapies are so seductive. “Modern medicine can appear callous and insensitive,” he writes, while alternative healers make patients feel empowered.

But Offit adds: “All therapies should be held to the same high standard of proof; otherwise we’ll continue to be hoodwinked by healers who ask us to believe in them rather than in the science that fails to support their claims.”

Many brilliant folks, such as Apple’s Steve Jobs, have fallen for unproven remedies.

Offit argues there should be no such thing as “alternative medicine.” If a drug works, it’s good care. If it doesn’t, it shouldn’t be used.

Skip the Supplements- New York Times editorial 12/15/2013 – by Paul Offit and Sarah Erush

PHILADELPHIA — PARENTS whose children are admitted to our hospital occasionally bring along something extra to help with their care: dietary supplements, like St. John’s wort to ameliorate mild depression or probiotics for better health.

Here’s the problem: The Joint Commission, which is responsible for hospital accreditation in the United States, requires that dietary supplements be treated like drugs. It makes sense: Vitamins, amino acids, herbs, minerals and other botanicals have pharmacological effects. So they are drugs.

But the Food and Drug Administration doesn’t regulate dietary supplements as drugs — they aren’t tested for safety and efficacy before they’re sold. Many aren’t made according to minimal standards of manufacturing (the F.D.A. has even found some of the facilities where supplements are made to be contaminated with rodent feces and urine). And many are mislabeled, accidentally or intentionally. They often aren’t what they say they are. For example:

In 2003, researchers tested “ayurvedic” remedies from health food stores throughout Boston. They found that 20 percent contained potentially harmful levels of lead, mercury or arsenic.

In 2008, two products were pulled off the market because they were found to contain around 200 times more selenium (an element that some believe can help prevent cancer) than their labels said. People who ingested these products developed hair loss, muscle cramps, diarrhea, joint pain, fatigue and blisters.

Last summer, vitamins and minerals made by Purity First Health Products in Farmingdale, N.Y., were found to contain two powerful anabolic steroids. Some of the women who took them developed masculinizing symptoms like lower voices and fewer menstrual periods.

Last month, researchers in Ontario found that popular herbal products like those labeled St. John’s wort and ginkgo biloba often contained completely different herbs or contaminants, some of which could be quite dangerous.

The F.D.A. estimates that approximately 50,000 adverse reactions to dietary supplements occur every year. And yet few consumers know this.

Parents of children admitted to our hospital often request that we continue treating their child with dietary supplements because they believe in them, even if that belief isn’t supported by evidence. More disturbing were the times when children were taking these supplements without our knowledge. Doctors always ask parents if their children are taking any medicines. Unfortunately, because most parents don’t consider dietary supplements to be drugs, we often never knew about their use, let alone whether they might react dangerously with the child’s other treatments.

The F.D.A. has the mandate, but not the manpower, to oversee the labeling and manufacture of these supplements. In the meantime, doctors — and consumers — are on their own.

Our hospital has acted to protect the safety of our patients. No longer will we administer dietary supplements unless the manufacturer provides a third-party written guarantee that the product is made under the F.D.A.’s “good manufacturing practice” (G.M.P.) conditions, as well as a Certificate of Analysis (C.O.A.) assuring that what is written on the label is what’s in the bottle.

The good news is that we’ve been able to find some vitamins, amino acids, minerals and a handful of other supplements that meet this standard. For example, melatonin has been shown to affect sleep cycles and has a record of safety, and we identified a product that met manufacturing and labeling standards.

The bad news is that this was a vanishingly small percentage of the total group. Around 90 percent of the companies we reached out to for verification never responded. They didn’t call us back, or their email or manufacturing addresses changed overnight. Of the remainder, many manufacturers refused to provide us with either a statement of G.M.P. or a C.O.A.; in other words, they refused to guarantee that their products were what they said they were. Others lied; they said they met G.M.P. standards, but a call to the F.D.A. revealed they had been fined for violations multiple times. Perhaps most surprising, some manufacturers willingly furnished information that their product didn’t meet standards — like one company that provided a C.O.A. showing that its product contained 47,000 International Units of beta-carotene, when the label stated 25,000.

Now, when parents in our hospital still want to use products whose quality can’t be assured, we ask them to sign a waiver stating that the supplement may be dangerous, and that most have not been studied for their effectiveness. “Use of an agent for which there are no reliable data on toxicity and drug interactions,” the waiver reads, “makes it impossible to adequately monitor the patient’s acute condition or safely administer medications.”

What can other individuals who are concerned about supplement safety do? They can look for “U.S.P. Verified” on the label — this proves the supplement has been inspected and approved under the United States Pharmacopeial Convention. Unfortunately, fewer than 1 percent of the 55,000 or so supplements on the market bear this label. The real answer is that, until the day comes when medical studies prove that these supplements have legitimate benefits, and until the F.D.A. has the political backing and resources to regulate them like drugs, individuals should simply steer clear.

For too long, too many people have believed that dietary supplements can only help and never hurt. Increasingly, it’s clear that this belief is a false one.

Paul A. Offit is chief of the division of infectious diseases at the Children’s Hospital of Philadelphia, where Sarah Erush is the clinical manager in the pharmacy department.

Washington Post: Alternative medicines are popular, but do any of them really work?

by Paul Offit

If people want to burn fat, detoxify livers, shrink prostates, avoid colds, stimulate brains, boost energy, reduce stress, enhance immunity, prevent cancer, extend lives, enliven sex or eliminate pain, all they have to do is walk in to a vitamin store and look around.

The shelves will be lined with ginkgo or rose and orange oils touted as aids for memory; guarana and cordyceps for energy; chicory root for constipation; lemon balm oil, ashwagandha, eleuthero, Siberian ginseng and holy basil for stress; sage and black cohosh for menstrual pain; coconut oil and curry powder for Alzheimer’s disease; saw palmetto for prostate health; sandalwood bark to prevent aging; garlic for high cholesterol; peppermint oil for allergies; artichoke extract and green papaya for digestion; echinacea for colds; chondroitin sulfate and glucosamine for joint pain; milk thistle for hepatitis; St. John’s wort for depression; and tongkat ali for sexual potency.

The question, however, is: Which products work? And how do we know they work? Fortunately, thanks to James Lind, we can figure it out.

When Lind climbed aboard the HMS Salisbury intent on testing whether citrus was a cure for scurvy in 1740, he moved medicine from a faith-based system to an evidence-based system. No longer do we believe in treatments. We can test them to see whether they work.

Although the size and cost of clinical studies have increased dramatically since the days of Lind, the claims made about alternative remedies are testable, eminently testable.

In that sense, there’s no such thing as alternative medicine. If clinical trials show that a therapy works, it’s good medicine. And if a therapy doesn’t work, then it’s not an alternative.

For example, Hippocrates used the leaves of the willow plant to treat headaches and muscle pains. By the early 1800s, scientists had isolated the active ingredient: aspirin. In the 1600s, a Spanish physician found that the bark of the cinchona tree treated malaria. Later, cinchona bark was shown to contain quinine, a medicine now proven to kill the parasite that causes malaria. In the late 1700s, William Withering used the foxglove plant to treat people with heart failure. Later, foxglove was found to contain digitalis, a drug that increases heart contractility. More recently, artemisia, an herb used by Chinese healers for more than a thousand years, was found to contain another anti-malaria drug, which was later called artemisinin.

“Herbal remedies are not really alternative,” writes Steven Novella, a Yale neurologist. “They have been part of scientific medicine for decades, if not centuries. Herbs are drugs, and they can be studied as drugs.”

Looking at the claims

In many case, though, when natural products have been put to the test, they’ve fallen short of their claims. For instance, although mainstream medicine hasn’t found a way to treat dementia or enhance memory, practitioners of alternative medicine claim that they have: ginkgo biloba. As a consequence, ginkgo is one of the 10 most commonly used natural products.

Yet between 2000 and 2008, the National Institutes of Health funded a collaborative study by the University of Washington, the University of Pittsburgh, Wake Forest University, Johns Hopkins University and the University of California at Davis to determine whether ginkgo worked. More than 3,000 elderly adults were randomly assigned to receive ginkgo or a placebo. Decline in memory and onset of dementia were the same in both groups. In 2012, a study of more than 2,800 adults found that ginkgo didn’t ward off Alzheimer’s disease.

Another example is St. John’s wort. Every year, 10 million people suffer major depression in the United States, and every year 35,000 people kill themselves. Depression is a serious illness; to treat it, scientists have developed medicines that alter brain chemicals such as serotonin. Called selective serotonin reuptake inhibitors (SSRIs), these drugs are licensed by the FDA and have been shown to help with severe depression.

But some people have heard there’s a more natural, safer way to treat severe depression: St. John’s wort. Because so many people use the herb and because depression, if not properly treated, can lead to suicide, researchers studied it. Between November 1998 and January 2000, 11 academic medical centers randomly assigned 200 outpatients to receive St. John’s wort or a placebo: The results showed no difference in any measure of depression.

Another favorite home remedy is garlic, to lower cholesterol. Because high cholesterol is associated with heart disease, because heart disease is a leading cause of death, because lipid-lowering agents lower cholesterol and because many people are choosing garlic instead of lipid-lowering agents, researchers studied it. In 2007, Christopher Gardner and co-workers at Stanford University School of Medicine evaluated the effects of garlic on 192 adults with high levels of low-density lipoprotein cholesterol (bad cholesterol). Six days a week for six months, participants received either raw garlic, powdered garlic, aged garlic extract or a placebo. After checking cholesterol levels monthly, investigators concluded, “None of the forms of garlic used in this study . . . had statistically or clinically significant effects on low-density lipoprotein cholesterol or other plasma lipid concentrations in adults with moderate hypercholesterolemia.”

Saw palmetto for the prostate is also popular. As a man ages, his prostate enlarges, which blocks the flow of urine. If untreated, prostate enlargement can cause urinary tract infections, bladder stones and kidney failure. Medicines that relax muscles within the prostate or reduce its size have been available for years. But more than 2 million men turn to saw palmetto instead.

In 2006, the National Center for Complementary and Alternative Medicine, part of the National Institutes of Health, supported a study at the University of California at San Francisco, the San Francisco Veterans Affairs Medical Center and Northern California Kaiser Permanente. Investigators assigned 225 men with moderate to severe symptoms of prostate enlargement to receive either saw palmetto or a placebo twice daily for a year: They found no difference between the two groups in urinary flow rate, prostate size or quality of life.

Five years later, the study was repeated with 369 men, this time with higher doses. Again, no change in urinary symptoms. “Now we know that even very high doses of saw palmetto make absolutely no difference,” said study author Gerald Andriole. “It clearly does not work any better than a sugar pill.”

Another popular remedy is milk thistle, which some have said can help patients with chronic hepatitis or other liver problems.

In 2011, Michael Fried of the University of North Carolina at Chapel Hill led a group of investigators testing those claims. More than 150 people infected with hepatitis C virus were given either milk thistle or a placebo. Then investigators determined the amount of liver damage, as well as the quantities of hepatitis C virus in blood. They found no difference between the two groups.

And what about chondroitin sulfate and glucosamine for joint pain? In 2006, Daniel Clegg of the University of Utah led a group of investigators to see whether it worked. They studied more than 1,500 people with knee osteoarthritis who were given either chondroitin sulfate alone, glucosamine alone, both, a placebo or Celebrex (an FDA-licensed anti-inflammatory drug). Only Celebrex worked for all subgroups in the study.

One of the most popular herbal remedies in the United States is echinacea. Used to treat colds, it’s a $130-million-a-year business. In 2003, James Taylor and co-workers at the University of Washington in Seattle studied more than 400 children with colds who had received either echinacea or a placebo for 10 days. The only difference: Children taking echinacea were more likely to develop a rash.

NEW REPUBLIC: The Quackish Cult of Alternative Medicine

Dr Paul Offit’s battle against charlatanism

by Jerome Groopman/ October 19, 2013

Not long ago, I cared for a middle-aged attorney who had a sarcoma. This kind of cancer arises from connective tissues like muscle and bone; if confined, it usually can be cured. But in this woman’s case, the malignancy was discovered after it had spread from her thigh to her lungs and liver. She initially was treated with chemotherapy, and the tumors shrank; but a year later, they grew again.

My patient told me that she was a clear-eyed and rational
person who made decisions based on facts: she would do so about her treatment, much the way she did in her practice as a lawyer. She underwent a series of increasingly arduous therapies, but her condition worsened as the cancer grew in vital organs, and she felt increasingly desperate. Friends, with what she acknowledged as good intentions, sent her reports from the Internet of “cancer cures,” which included cleansing her body of toxins with coffee enemas, ingesting solutions made from Chinese herbs, passing her plasma over resins. At one of our last appointments, my patient recounted how hard it was not to give in and chase illusory treatments. “I so much want to live,” she said.

Typically absent from the claims about many “alternative treatments” are their risks. The significant harms that they can pose form the fabric of Paul Offit’s important and timely book. Offit writes in a lucid and flowing style, and grounds a wealth of information within forceful and vivid narratives. This makes his argument—that we should be guided by science—accessible to a wide audience.

Offit is a pugilist in the battle against charlatanism, and he lands punch after punch with hard facts about harms……

The Atlantic ” The Vitamin Myth: Why We Think We Need Supplements”

By Paul Offit

On October 10, 2011, researchers from the University of Minnesota found that women who took supplemental multivitamins died at rates higher than those who didn’t. Two days later, researchers from the Cleveland Clinic found that men who took vitamin E had an increased risk of prostate cancer. “It’s been a tough week for vitamins,” said Carrie Gann of ABC News.

These findings weren’t new. Seven previous studies had already shown that vitamins increased the risk of cancer and heart disease and shortened lives. Still, in 2012, more than half of all Americans took some form of vitamin supplements. What few people realize, however, is that their fascination with vitamins can be traced back to one man. A man who was so spectacularly right that he won two Nobel Prizes and so spectacularly wrong that he was arguably the world’s greatest quack.

In 1931, Linus Pauling published a paper in the Journal of the American Chemical Society titled “The Nature of the Chemical Bond.” Before publication, chemists knew of two types of chemical bonds: ionic, where one atom gives up an electron to another; and covalent, where atoms share electrons. Pauling argued that it wasn’t that simple — electron sharing was somewhere between ionic and covalent. Pauling’s idea revolutionized the field, marrying quantum physics with chemistry. His concept was so revolutionary in fact that when the journal editor received the manuscript, he couldn’t find anyone qualified to review it. When Albert Einstein was asked what he thought of Pauling’s work, he shrugged his shoulders. “It was too complicated for me,” he said. For this single paper, Pauling received the Langmuir Prize as the most outstanding young chemist in the United States, became the youngest person elected to the National Academy of Sciences, was made a full professor at Caltech, and won the Nobel Prize in Chemistry. He was 30 years old……

Bad Faith

Although America is the most medically advanced place in the world, many people disregard modern medicine in favor of using their faith to fight life-threatening illnesses. In twenty-first century America, how could this be happening?Read more